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Simvastatin Side Effects

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Common Simvastatin Side Effects


The most commonly reported Simvastatin side effects (click to view or check a box to report):

Rhabdomyolysis (1122)
Myalgia (992)
Renal Failure Acute (459)
Blood Creatine Phosphokinase Increased (458)
Fatigue (445)
Pain In Extremity (403)
Muscular Weakness (399)
Asthenia (367)
Arthralgia (352)
Muscle Spasms (301)
Pain (282)
Dyspnoea (268)
Dizziness (261)
Nausea (236)
Diarrhoea (221)
Fall (217)
Alanine Aminotransferase Increased (217)
Gait Disturbance (195)
Headache (194)
Myositis (193)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Simvastatin Side Effects Reported to FDA



Simvastatin Side Effect Report#9998874
Pain In Extremity, Back Pain, Asthenia, Fatigue, Inflammation, Hypoaesthesia
This is a report of a 54-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: hypercholesterolaemia, who was treated with Simvastatin (dosage: 40mg. Dose Increased In 2008, start time: 2003), combined with:
  • Starflower Oil
and developed a serious reaction and side effect(s): Pain In Extremity, Back Pain, Asthenia, Fatigue, Inflammation, Hypoaesthesia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Simvastatin treatment in female patients, resulting in Pain In Extremity side effect. The patient was hospitalized and became disabled.
Simvastatin Side Effect Report#9997880
Completed Suicide
This report suggests a potential Simvastatin Completed Suicide side effect(s) that can have serious consequences. A 34-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Simvastatin (dosage: NA) starting NS. After starting Simvastatin the patient began experiencing various side effects, including: Completed SuicideAdditional drugs used concurrently:
  • Carvedilol
The patient was hospitalized. Although Simvastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Completed Suicide, may still occur.
Simvastatin Side Effect Report#9997238
Sexual Dysfunction, Decreased Appetite, Fatigue, Insomnia, Myalgia
This Sexual Dysfunction problem was reported by a consumer or non-health professional from GB. A 76-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: surgery. On
Jan 03, 2012 this consumer started treatment with Simvastatin (dosage: 20 Mg, 1 /1 Day). The following drugs were being taken at the same time:
  • Aspirin
  • Ramipril
When using Simvastatin, the patient experienced the following unwanted symptoms/side effects: Sexual Dysfunction, Decreased Appetite, Fatigue, Insomnia, MyalgiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Sexual Dysfunction, may become evident only after a product is in use by the general population.
Simvastatin Side Effect Report#9996398
Parkinson^s Disease, Blood Pressure Increased
This Parkinson^s Disease side effect was reported by a consumer or non-health professional from BR. A male patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Simvastatin (drug dosage: 1 Df, Qd Once In The Morning (20 Mg)), which was initiated on NS. Concurrently used drugs:
  • Clopidogrel (1 Df, Qd Once During Lunch)
  • Clopidogrel
  • Procoralan (Unk Ukn, Unk)
  • Vastarel (Unk Ukn, Unk)
  • Monocordil (Unk Ukn, Unk)
  • Monocordil
  • Omeprazole (Unk Ukn, Unk)
  • Prolopa (Unk Ukn, Unk)
.After starting to take Simvastatin the consumer reported adverse symptoms, such as: Parkinson^s Disease, Blood Pressure IncreasedThese side effects may potentially be related to Simvastatin.
Simvastatin Side Effect Report#9996270
Myalgia, Muscular Weakness
This is a report of a 49-year-old male patient (weight: NA) from SE, suffering from the following health symptoms/conditions: NA, who was treated with Simvastatin Arrow (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Myalgia, Muscular Weakness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Simvastatin Arrow treatment in male patients, resulting in Myalgia side effect.
Simvastatin Side Effect Report#9995005
Muscle Spasms
This report suggests a potential Simvastatin Muscle Spasms side effect(s) that can have serious consequences. A 62-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood cholesterol and used Simvastatin (dosage: By Mouth) starting NS. After starting Simvastatin the patient began experiencing various side effects, including: Muscle SpasmsAdditional drugs used concurrently:
  • Inhaler
  • Alkaseler Cold Medicine
  • Zoloft
Although Simvastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Muscle Spasms, may still occur.
Simvastatin Side Effect Report#9994765
Hepatitis, Myalgia, Weight Decreased, Lethargy, Asthenia
This Hepatitis problem was reported by a physician from GB. A 82-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: dyslipidaemia. On
Mar 14, 2011 this consumer started treatment with Simvastatin (dosage: NA). The following drugs were being taken at the same time:
  • Allopurinol (allopurinol)
  • Aspirin (acetylsalicylic Acid)
  • Perindopril (perindopril)
When using Simvastatin, the patient experienced the following unwanted symptoms/side effects: Hepatitis, Myalgia, Weight Decreased, Lethargy, AstheniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatitis, may become evident only after a product is in use by the general population.
Simvastatin Side Effect Report#9994729
Back Pain, Inflammation, Pain In Extremity, Hypoaesthesia, Fatigue, Asthenia
This Back Pain side effect was reported by a consumer or non-health professional from GB. A 54-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypercholesterolaemia.The patient was prescribed Simvastatin (drug dosage: Unk), which was initiated on 2003. Concurrently used drugs:
  • Borage Oil
.After starting to take Simvastatin the consumer reported adverse symptoms, such as: Back Pain, Inflammation, Pain In Extremity, Hypoaesthesia, Fatigue, AstheniaThese side effects may potentially be related to Simvastatin. The patient was hospitalized and became disabled.
Simvastatin Side Effect Report#9993083
Myalgia, Asthenia, Muscle Spasms, Pain, Pain, Abnormal Dreams
This is a report of a 69-year-old male patient (weight: NA) from SE, suffering from the following health symptoms/conditions: NA, who was treated with Simvastatin (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Myalgia, Asthenia, Muscle Spasms, Pain, Pain, Abnormal Dreams after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Simvastatin treatment in male patients, resulting in Myalgia side effect.
Simvastatin Side Effect Report#9990880
Aspartate Aminotransferase Increased
This report suggests a potential Simvastatin Aspartate Aminotransferase Increased side effect(s) that can have serious consequences. A 55-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypercholesterolaemia and used Simvastatin (dosage: NA) starting
Jun 30, 2013. After starting Simvastatin the patient began experiencing various side effects, including: Aspartate Aminotransferase IncreasedAdditional drugs used concurrently:
  • Citalopram
  • Clozapine
  • Co
  • Ferrous Sulfate
  • Lorazepam
  • Metoprolol
  • Oxybutynin
  • Miralax
Although Simvastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Aspartate Aminotransferase Increased, may still occur.
Simvastatin Side Effect Report#9990871
Liver Function Test Abnormal, Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
This Liver Function Test Abnormal problem was reported by a pharmacist from US. A 35-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hyperlipidaemia. On NS this consumer started treatment with Simvastatin (dosage: Simvastatin 40mg Tablet Po 8:30). The following drugs were being taken at the same time:
  • Acetaminophen
  • Benzotropine
  • Duloxetine
  • Omeprazole
When using Simvastatin, the patient experienced the following unwanted symptoms/side effects: Liver Function Test Abnormal, Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase IncreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Liver Function Test Abnormal, may become evident only after a product is in use by the general population.
Simvastatin Side Effect Report#9988718
Lethargy, Weight Decreased, Hepatitis, Myalgia, Asthenia
This Lethargy side effect was reported by a consumer or non-health professional from GB. A 82-year-old male patient (weight:NA) experienced the following symptoms/conditions: dyslipidaemia.The patient was prescribed Simvastatin (drug dosage: NA), which was initiated on
Mar 14, 2011. Concurrently used drugs:
  • Allopurinol
  • Aspirin
  • Perindopril
.After starting to take Simvastatin the consumer reported adverse symptoms, such as: Lethargy, Weight Decreased, Hepatitis, Myalgia, AstheniaThese side effects may potentially be related to Simvastatin.
Simvastatin Side Effect Report#9985463
Head Injury, Fall, Victim Of Spousal Abuse, Contusion, Psoriasis, Rash, Dizziness, Amnesia
This is a report of a 79-year-old female patient (weight: NA) from AU, suffering from the following health symptoms/conditions: NA, who was treated with Simvastatin (dosage: Unk, start time: NS), combined with:
  • Cartia /00002701/ (Unk)
  • Tenormin (Unk)
  • Tritace (Unk)
  • Thyroxine (Unk)
  • Atacand (Unk)
and developed a serious reaction and side effect(s): Head Injury, Fall, Victim Of Spousal Abuse, Contusion, Psoriasis, Rash, Dizziness, Amnesia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Simvastatin treatment in female patients, resulting in Death side effect.
Simvastatin Side Effect Report#9981254
Dementia, Fear, Product Substitution Issue, Memory Impairment
This report suggests a potential Simvastatin 40 Mg Dementia side effect(s) that can have serious consequences. A 73-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood cholesterol increased,blood triglycerides increased and used Simvastatin 40 Mg (dosage: NA) starting
Sep 02, 2013. After starting Simvastatin 40 Mg the patient began experiencing various side effects, including: Dementia, Fear, Product Substitution Issue, Memory ImpairmentAdditional drugs used concurrently: NA. Although Simvastatin 40 Mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dementia, may still occur.
Simvastatin Side Effect Report#9981075
Myalgia, Nasopharyngitis, Dizziness, Constipation, Dyspepsia, Headache, Pain
This Myalgia problem was reported by a consumer or non-health professional from GB. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood cholesterol increased. On
Jan 01, 2010 this consumer started treatment with Simvastatin (dosage: NA). The following drugs were being taken at the same time:
  • Warfarin
When using Simvastatin, the patient experienced the following unwanted symptoms/side effects: Myalgia, Nasopharyngitis, Dizziness, Constipation, Dyspepsia, Headache, PainThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myalgia, may become evident only after a product is in use by the general population.
Simvastatin Side Effect Report#9980927
Abdominal Distension
This Abdominal Distension side effect was reported by a consumer or non-health professional from GB. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Simvastatin (simvastatin) (drug dosage: NA), which was initiated on
Nov 13, 2013. Concurrently used drugs:
  • Atorvastatin
  • Levothyroxine
.After starting to take Simvastatin (simvastatin) the consumer reported adverse symptoms, such as: Abdominal DistensionThese side effects may potentially be related to Simvastatin (simvastatin).
Simvastatin Side Effect Report#9980821
Hepatitis, Myalgia, Lethargy, Asthenia, Weight Decreased
This is a report of a 82-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: dyslipidaemia, who was treated with Simvastatin (dosage: Unk, start time:
Mar 14, 2011), combined with:
  • Allopurinol
  • Aspirin
  • Perindopril
and developed a serious reaction and side effect(s): Hepatitis, Myalgia, Lethargy, Asthenia, Weight Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Simvastatin treatment in male patients, resulting in Hepatitis side effect.
Simvastatin Side Effect Report#9975791
Abdominal Distension
This report suggests a potential Simvastatin Abdominal Distension side effect(s) that can have serious consequences. A 67-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Simvastatin (dosage: NA) starting
Dec 19, 2013. After starting Simvastatin the patient began experiencing various side effects, including: Abdominal DistensionAdditional drugs used concurrently:
  • Atorvastatin
  • Levothyroxine
Although Simvastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Distension, may still occur.
Simvastatin Side Effect Report#9975742
Blood Glucose Increased, Muscle Spasms, Myopathy, Neuropathy Peripheral, Sleep Disorder
This Blood Glucose Increased problem was reported by a consumer or non-health professional from GB. A 48-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201211 this consumer started treatment with Simvastatin (dosage: NA). The following drugs were being taken at the same time:
  • Atorvastatin Calcium
  • Pravastatin Sodium
  • Aspirin
  • Lantus
  • Novorapid
When using Simvastatin, the patient experienced the following unwanted symptoms/side effects: Blood Glucose Increased, Muscle Spasms, Myopathy, Neuropathy Peripheral, Sleep DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Blood Glucose Increased, may become evident only after a product is in use by the general population.
Simvastatin Side Effect Report#9973678
Muscle Rupture, Fall, Atrial Fibrillation
This Muscle Rupture side effect was reported by a health professional from FR. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Simvastatin (drug dosage: 20 Mg, Daily), which was initiated on 2007. Concurrently used drugs:
  • Cordarone (200 Mg, (per Day, 5 Days Per Week))
  • Cordarone (200 Mg, Daily)
  • Xarelto (20 Mg, Daily)
  • Nisisco (1 Df, Daily)
  • Mediatensyl (120 Mg, Daily)
  • Hemigoxine Nativelle (0.125 Mg, Daily)
  • Stagid (2100 Mg, Daily)
  • Januvia (1 Df, Daily)
.After starting to take Simvastatin the consumer reported adverse symptoms, such as: Muscle Rupture, Fall, Atrial FibrillationThese side effects may potentially be related to Simvastatin.
Simvastatin Side Effect Report#9970971
Hypersensitivity, Arthritis, Muscle Spasms, Tenderness, Arthralgia, Muscle Spasms, Gait Disturbance, Paraesthesia, Fear
This is a report of a 59-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: blood cholesterol increased, who was treated with Simvastatin (dosage: Taken By Mouth, start time:
Nov 11, 2013), combined with: NA. and developed a serious reaction and side effect(s): Hypersensitivity, Arthritis, Muscle Spasms, Tenderness, Arthralgia, Muscle Spasms, Gait Disturbance, Paraesthesia, Fear after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Simvastatin treatment in female patients, resulting in Hypersensitivity side effect.
Simvastatin Side Effect Report#9970903
Muscle Spasms, Muscle Spasms, Muscle Spasms, Pain, Toxicity To Various Agents
This report suggests a potential Simvastatin Muscle Spasms side effect(s) that can have serious consequences. A 57-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypercholesterolaemia and used Simvastatin (dosage: 1 Pill Once Daily Taken By Mouth) starting
Nov 16, 2013. After starting Simvastatin the patient began experiencing various side effects, including: Muscle Spasms, Muscle Spasms, Muscle Spasms, Pain, Toxicity To Various AgentsAdditional drugs used concurrently: NA. Although Simvastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Muscle Spasms, may still occur.
Simvastatin Side Effect Report#9969996
Abdominal Distension
This Abdominal Distension problem was reported by a physician from GB. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 19, 2013 this consumer started treatment with Simvastatin (dosage: NA). The following drugs were being taken at the same time:
  • Atorvastatin
  • Levothyroxine
When using Simvastatin, the patient experienced the following unwanted symptoms/side effects: Abdominal DistensionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Distension, may become evident only after a product is in use by the general population.
Simvastatin Side Effect Report#9969719
Myalgia, Lethargy, Asthenia, Weight Decreased, Hepatitis
This Myalgia side effect was reported by a physician from GB. A 82-year-old male patient (weight:NA) experienced the following symptoms/conditions: dyslipidaemia.The patient was prescribed Simvastatin (drug dosage: NA), which was initiated on
Mar 14, 2011. Concurrently used drugs:
  • Aspirin
  • Allopurinol
  • Perindopril/perindopril Erbumine
.After starting to take Simvastatin the consumer reported adverse symptoms, such as: Myalgia, Lethargy, Asthenia, Weight Decreased, HepatitisThese side effects may potentially be related to Simvastatin.
Simvastatin Side Effect Report#9969429
Nasopharyngitis, Myalgia, Headache, Constipation, Dyspepsia, Dizziness
This is a report of a 75-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: blood cholesterol increased, who was treated with Simvastatin (dosage: NA, start time:
Jan 01, 2010), combined with:
  • Warfarin
and developed a serious reaction and side effect(s): Nasopharyngitis, Myalgia, Headache, Constipation, Dyspepsia, Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Simvastatin treatment in male patients, resulting in Nasopharyngitis side effect. The patient was hospitalized.


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The appearance of Simvastatin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

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What are common Simvastatin Side Effects for Women?

Women Side EffectsReports
Myalgia 383
Rhabdomyolysis 357
Fatigue 224
Muscular Weakness 219
Pain In Extremity 191
Arthralgia 179
Pain 175
Muscle Spasms 149
Blood Creatine Phosphokinase Increased 148
Asthenia 141

What are common Simvastatin Side Effects for Men?

Men Side EffectsReports
Rhabdomyolysis 752
Myalgia 599
Renal Failure Acute 369
Blood Creatine Phosphokinase Increased 304
Asthenia 221
Pain In Extremity 208
Fatigue 206
Muscular Weakness 175
Arthralgia 169
Muscle Spasms 142

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Simvastatin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Discuss Simvastatin Side Effects

    Did You Have a Simvastatin Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Simvastatin for You?

    Exceeded Expectations
    Effective
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    Simvastatin Safety Alerts, Active Ingredients, Usage Information

    NDC0093-7152
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameSimvastatin
    NameSimvastatin
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20060627
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)SIMVASTATIN
    Strength(s)5
    Unit(s)mg/1
    Pharma ClassHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

    Simvastatin Dosage, Warnings, Usage.

    Side Effects reported to FDA: 8348

    Simvastatin safety alerts: 2011 2010 2008

    Reported deaths: 559

    Reported hospitalizations: 3020

    Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations

    Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor


     

    [UPDATED 12/15/2011] FDA notified the public that it has revised the dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction.

     

    [Posted 06/08/2011]

    AUDIENCE: Family Practice, Cardiology, Pharmacy

    ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal. FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines.

    BACKGROUND: The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).

    RECOMMENDATION: Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.  


    Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [12/15/2011 - Drug Safety Communication - FDA
    [06/08/2011 - Drug Safety Communication - FDA]
    [06/08/2011 - News Release - FDA]
    [06/08/2011 - Consumer Update - FDA

    Previous MedWatch Alert

    [03/19/2010]

    Latest Simvastatin clinical trials